G/SPS/N/BRA/1918  
 
26 March 2021  
(21-2525) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved:   
2. Agency responsible:  Brazilian Health Regulatory Agency (ANVISA)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  HS Code(s): pasture; ICS Code(s): 13, 65  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft resolution number 1020, 11 March 2021, 
regarding the active ingredient A41 - AMICARBAZONA (amicarbazone) of the Monograph 
List of Active Ingredients for Pesticides, Hou sehold Cleaning Products and Wood 
Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian 
Official Gazette (DOU - Diário Oficial da União) of 2 September 2003 . Language(s):  
Portuguese . Number of pages:  4 
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6243417/CONSULTA+P%C3%9ABLICA+
N+1020+GGTOX.pdf/5a914cca -70fe-4990-b2d1-6b873f893bbc  
Comment  form: 
http://antigo.anvisa.gov.br/documents/111215/0/Formul%C3%A1rio+Padr%C3%A3o+
Consulta+P%C3 %BAblica+ -+GGTOX/5faccd95 -356b-4e0e-91d1-9f318e0aa370  
6. Description of content:  This Draft resolution incorporates the following changes for the 
active ingredient A41 – AMICARBAZONA  (amicarbazone) from the Relation of 
Monographies of Active Ingredients o f Pesticides, Household Cleaning Products and Wood 
Preservers, all in the modality of pre emergency use (application):  
− includes the pasture culture with MRL and safety security period of "Non -food use";  
− includes the phrase at item "m": Acute Reference Dose  (ARfD): 0 .1 mg/kg b.w. 
(source: EPA*, 2005);  
− includes the phrase: "*Environmental Protection Agency";  
− includes the phrase at item "n": "for the purpose of residue definition for conformity 
to MRL and dietary risk assessment, it will be considered the sum of the active 
ingredient amicarbazone and its metabolits DA Amiicarbazone and iPr -2-OH DA, 
expressed as amicarbazone".  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/BRA/1918  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : CAC/MRL 1 Maximum  Residue Limits (MRLs) for 
Pesticides  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  Brazilian MRLs are established based on scientific methodology 
consistent with interna tional best practices. Countries usually set MRLs according to the 
Good Agricultural Practice (GAP) applicable to their region. Agricultural chemical use 
patterns differ between different production regions and countries as pests, diseases and 
environmenta l factors vary. This means that Brazilian MRLs for agricultural chemicals in 
food may differ from Codex standards. However, when a product differs from Brazilian 
MRLs, but is in conformity to Codex standards, it may be imported, provided that the risk 
assessment does not indicate an unacceptable risk to Brazilian consumers.  
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : To be determined after the end of the 
consultation period.  
Propose d date of publication (dd/mm/yy) : To be determined after the end of the 
consultation period.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : To be determined after the end of the consultation period.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 15 May 2021  
Agency or authority designated to handl e comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br  
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Assessoria de Assuntos Internacionais - AINTE  
International Affairs Office  
Agência Nacional de Vigilância Sanitária - Anvisa  
Brazilian Health Regulatory Agency  
Tel: +(55 61) 3462 5402/5404/5406  
E-mail: rel@anvisa.gov.br